Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668134
• Other study ID #: 09-1345 / 201107319
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2012
• Last updated: February 16, 2017
• Start date: December 16, 2009
• Est. completion date: December 22, 2015

Study information

• Verified date: February 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 22, 2015
• Est. primary completion date: August 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18

• Karnofsky Performance Status of = 60

• Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)

• 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.

• Local surgical resection is not possible due to tumor or patient factors

• Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.

• Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment

• Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment

• Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.

• Able to provide signed informed consent

Exclusion Criteria:

• Childs-Pugh score 9 or more

• ALT or AST = 6 x upper limit of normal

• Prior history of abdominal irradiation

• Women who are pregnant or nursing

• Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.

• Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.

• Undergone prior radiation therapy to the abdomen.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Radiation:
• Stereotactic radiation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.		Up to 90 days after end of radiation therapy
Secondary	Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.		Up to 60 days after end of radiation therapy
Secondary	Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.		Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease
Secondary	Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.		Baseline to time of death
Secondary	Measure the response rates associated with using SBRT in patients with resectable HCC and IHC		Baseline to the first date of recurrance or progressive disease

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine